Status:
COMPLETED
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hodgkin Disease
Hodgkin's Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease
Detailed Description
To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic...
Eligibility Criteria
Inclusion
- Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible.
- Age \< 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
- Phase 1 study component only: 1 or more of the following adverse risk factors
- Stage IV extranodal disease at relapse "B" symptoms
- Failure to achieve minimal disease with most recent chemotherapy (single lymph nodes \< 2 cm or \>75% reduction in a bulky tumor mass and bone marrow involvement \< 10%)
- Progression during induction or salvage therapy
- Phase 2 study component only: No risk factor criteria
- Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of response to last chemotherapy, within 4 weeks of registration. Gallium scan or positron emission tomography (PET) scan confirmation of disease within 4 weeks of registration is highly recommended
- Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
- Women of child-bearing potential and sexually active males expected to use an accepted and effective method of birth control
- Pretreatment serum bilirubin \< 2 x the institutional upper limit of normal (ULN) (within 28 days prior to registration)
- Serum creatinine \< 2 x the institutional ULN (within 28 days prior to registration)
- Measured or estimated creatinine clearance \> 60 cc/min by the following formula (within 28 days prior to registration):
- Estimated Creatinine Clearance = (140 age) x WT(kg) x 0.85 (if female) x creatinine (mg/dL)
- Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of active cardiac disease (within 42 days prior to registration)
- Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of doxorubicin or with any history of cardiac disease must have a radionuclide ejection fraction (within 42 days prior to registration). If the ejection fraction is 40 to 50%, the patient will have a cardiology consult
- Corrected diffusion capacity \> 55%
- Written informed consent in accordance with institutional and federal guidelines
Exclusion
- Positive HIV antibody test (must be conducted within 42 days of registration)
- No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy
- Pregnant
- Breast-feeding
- Requiring therapy for:
- Coronary artery disease
- Cardiomyopathy
- Dysrhythmia, or
- Congestive heart failure
- Over age 50 and has received chest irradiation or a total of 300 mg/m\^2 of doxorubicin
- History of cardiac disease and the ejection fraction is \< 40% (radionuclide ejection fraction must be within 42 days of registration)
- Known allergy to etoposide
- History of Grade 3 hemorrhagic cystitis with cyclophosphamide
- History of grade 2 or greater sensory or motor peripheral neuropathy due to prior vinca alkaloid use
- No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; or other cancer for which the patients has been disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00388349
Start Date
September 1 2001
End Date
September 1 2010
Last Update
June 14 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305